Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion

Protocol title： Outcome evaluation for burn scar therapy-laser and surgery in patients in Formosa Fun Coast Explosion

Objectives： The goal of this study is to evaluate the effectiveness of both lasers and operations on patients with major burn scar(>20% TBSA).

Study Overview

• Status: Completed
• Conditions: Patients With Major Burn Injury in Formosa FunCost Explosion
• Intervention / Treatment: Procedure: Laser and Surgery

Detailed Description

Background： There is no gold standard treatment for burn scar treatment, especially for those with major burn scar. In the Formosa Fun-Coast Dust Explosion in 2015, lots of patients with major burn scar suffer from severe pathologic burn scar syndromes. The gold of the study is to evaluate the efficacy of both lasers and operations on major burn scars treatment in the past two years.

Study Design： To take the assessment of scar into account, the investigators use both objectives and subjective methods to evaluate the scar condition. In addition to the scale of scar, the investigators also use both sonography and HRV system to evaluate the expressions of scar. All evaluated tools used are the same as those used in 20160201R and 20160202R. The investigators also used previous records to check the patient's scar condition before these treatments.

Hypothesis： After treatment, scar conditions should get better than before. However, the investigators need more scientific statistics to evaluate the improve rate.

Key words： Burn scar, burn scar syndromes. Scar laser treatment

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11101
    • Shin Kong Wu Ho Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. >20% major burn scar, for 3 years
2. patients in Formosa FunCost Explosion
3. offering medical records, including laser and treatments
4. available for questionnaire evaluation and others' evaluation
5. those are willing to receive both sonography on scars and HRV evaluation

Exclusion Criteria:

1. those aren't willing to offer medical records
2. those aren't willing to fill questionnaire
3. those aren't willing to receive sonography on scars

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Laser and Surgery in patients with major burn scars; Evaluating patients with major burn scar after laser and surgical treatments Multiple-directions evaluation, including senior plastic resident, young resident, professional burn surgeons, senior nurse with burn scar, one non-medical patients(usually patients' family and friends)	Procedure: Laser and Surgery; Laser and Surgery in patients with major burn scars Evaluating after three years treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients objective questionnaire	Patients objective questionnaires is used to evaluate subjects' sensation and life quality, in which pain, itchiness and sleep are evaluated by Visual Analogue Scale (VAS), Burn Itchiness Scale and Sleep Assessment Scale, respectively.	Week 0
Burn assessment by researchers	Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.	Week 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar evaluation by sonography (selective)	Burn scars in lower extremity are measured using 2-D problem sonography machine.	Week 0
Autonomic nervous system analysis (selective)	Autonomic nervous system analysis is performed by heart-rate variability machine (HRV MACHINE).	Week 0

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): January 27, 2019
• Study Completion (Actual): March 8, 2019

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: burn scar; laser; ultrapulse
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 20180606R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: lasers treatments, especially patients with major burn cases, are widely used. Therefore, we still consider the results after three years' treatments.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No